K962105 is an FDA 510(k) clearance for the PLANNED SOPHIED CLASSIC. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Planmed OY (Helsinki, FI). The FDA issued a Cleared decision on February 5, 1997, 250 days after receiving the submission on May 31, 1996.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K962105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 1996 |
| Decision Date | February 05, 1997 |
| Days to Decision | 250 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZH — System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1710 |